Tonix Pharmaceuticals Holding Corp. announced program updates related to the development of Tonmya, which is in Phase 3 development for the treatment of posttraumatic stress disorder, or PTSD. The FDA notified the company that the Breakthrough Therapy designation, or BTD, granted for Tonmya for PTSD in December 2016 has been rescinded because interim analysis data on Tonmya from the HONOR study do not support the continuation of the BTD. The BTD granted to Tonmya was based on retrospective analysis of the effect of Tonmya 5.6 mg in the Phase 2 AtEase study in military-related PTSD, that shows a substantial improvement over existing therapies in military-related PTSD. Tonix CEO Seth Lederman commented, “The rescission of Breakthrough Therapy designation of Tonmya for PTSD does not alter our NDA plan and will have minimum impact on our future interactions with the FDA. We are on track to start imminently the Phase 3 RECOVERY trial in civilian and military-related PTSD. We are grateful for the guidance and continued support received from the FDA. We remain committed to expedite the development of Tonmya for PTSD, especially military-related PTSD.”
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